Actively Recruiting
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Led by Fudan University · Updated on 2025-01-27
39
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single-center, prospective, single-arm clinical trial, which intends to enroll patients with triple-negative breast cancer with brain metastases to receive ivonescimab combined with TROP2 ADC (such as sacituzumab govitecan) treatment until disease progression, intolerable toxicity, withdrawal of informed consent, or the investigator deems it necessary to discontinue the medication, and to collect data on the drug's efficacy and safety.
CONDITIONS
Official Title
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years, any gender
- ECOG performance status of 0 to 2
- Expected survival of at least 3 months
- Diagnosis of unresectable locally advanced, recurrent or metastatic triple-negative breast cancer with prior taxane treatment failure
- Available tissue pathology slides from primary or metastatic lesions for molecular analysis
- Brain metastases confirmed by MRI with at least one untreated lesion 1.0 cm or larger, or progression of treated lesions
- Cohort A: No prior central nervous system radiotherapy; new brain lesions after craniotomy allowed if no radiotherapy post-surgery and at least 2 weeks post-surgery
- Cohort B: Progression or new lesions after whole brain or stereotactic radiotherapy; patients with partially treated lesions eligible
- Use of stable dose mannitol or hormone treatment allowed before enrollment
- Adequate blood, liver, and kidney function
- Ability to understand study and provide informed consent
You will not qualify if you...
- Soft meningeal metastases confirmed by MRI or lumbar puncture
- Uncontrolled third-space effusions such as large pleural effusion or ascites
- Receipt of whole brain radiotherapy, chemotherapy, or surgery within 2 weeks before investigational drug treatment, or targeted/endocrine therapy within 1 week
- Previous use of monoclonal or bispecific antibodies targeting VEGF-A, PD-1/PD-L1/CTLA-4, or TROP2 ADC drugs
- Participation in other drug trials within 2 weeks before enrollment
- Receiving any anti-tumor treatment for other cancers
- Other malignant tumors within past 5 years except certain cured skin or thyroid cancers
- Severe heart diseases including congestive heart failure above NYHA class 2, recent unstable angina or myocardial infarction, significant arrhythmias, or other unsuitable heart conditions
- Known allergy to investigational drug components
- Uncontrolled serious infections
- History of immunodeficiency or organ transplantation; untreated active hepatitis B or C
- Use of live attenuated vaccines within 28 days before randomization or expected during study
- Active or suspected autoimmune diseases with exceptions for controlled or mild cases
- History of definite neurological or mental disorders including epilepsy or dementia
- Pregnancy, lactation, or unwillingness to use effective contraception
- Severe concomitant diseases that threaten safety or study completion
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer center
Shanghai, Shanghai Municipality, China, China 200032
Actively Recruiting
Research Team
J
Jian Zhang, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here